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Face Recognition Task for Facial Disfigurement
N/A
Waitlist Available
Led By Eduardo Rodriguez
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will help researchers understand how the brain processes information about self-facial recognition and how this changes after receiving a facial transplant.
Who is the study for?
This trial is for patients with severe facial disfigurement approved for face transplantation. They must be able to undergo MRI scans, give informed consent, and perform the recognition task well. Excluded are those with metal implants, pacemakers, certain medical conditions like epilepsy or heart disease, mental illness history, claustrophobia, or who may be pregnant.Check my eligibility
What is being tested?
The study uses fMRI to explore brain activity related to self-face recognition after facial transplantation. It aims to pinpoint brain areas involved in recognizing one's own face and track changes over time before injury, post-injury/pre-transplantation, and post-transplantation.See study design
What are the potential side effects?
Since this trial involves non-invasive fMRI scanning rather than medication or surgery (beyond the already planned transplant), typical side effects associated with drugs are not expected. However discomfort from lying still during scanning or anxiety within the confined space of an MRI machine could occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average percentage of the self in the morphs that participants judge to be "like self" for the self- face after surgery.
Average percentage of the self in the morphs that participants judge to be "like self" for the self- face before before surgery
Average percentage of the self in the morphs that participants judge to be "like self" for the self- face before disfigurement
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Post-Transplant Time PointExperimental Treatment1 Intervention
Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI). Patients for whom a pre-transplant fMRI was obtained will undergo functional MRI scanning at three-points post-transplant (approximately 2 and 4 months +/- 2 months post-operation and again at 1 year +/- 3 months post-transplant).
Group II: Pre-Transplant Time PointActive Control1 Intervention
Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI)
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,716 Total Patients Enrolled
Eduardo RodriguezPrincipal InvestigatorNYU Langone Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have epilepsy, diabetes, heart disease, thermoregulatory problems, and I am not pregnant or breastfeeding.I do not have mental illness, claustrophobia, or neurological conditions that affect MRI quality.I have been approved for a facial transplant due to severe disfigurement.I don't have any non-removable metal in my body that would make an MRI unsafe.I can perform tasks well and don't have conditions affecting how I see faces.
Research Study Groups:
This trial has the following groups:- Group 1: Post-Transplant Time Point
- Group 2: Pre-Transplant Time Point
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period for this investigation still open?
"According to clinicaltrials.gov, this trial is no longer accepting participants as the latest update was on September 7th 2022 and it first went live February 1st 2017. However, 35 other trials are still open for enrollment at present."
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